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Validation and 21 CFR Part 11 Compliance Certificate (ISO 13485 Software)
IMSXpress Document Control and QMS Management Software
Please download the current  Validation and CFR Title 21 Part 11 Compliance Certificate form this link:
Validation and CFR 21 Part 11 Certificate
PD-P11: 21 CFR Part 11 Compliance Traceability Matrix
Part 11 Requirement
IMSXpress Feature
11.10 Controls for closed systems
11.10 (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
IMSXpress software is validated to:
  • IEC 62304:2006 Medical device software -Software life cycle processes
  • IEC TR 80002 Medical device software - Guidance on the application of ISO 14971 to medical device software
  • FDA Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures - Validation, August 2001
11.10 (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.
Every document, record and attachment can be printed out or saved into an electronic file. Audit trail reports can also be printed out or saved.
11.10 (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
Records are saved to a database on a server. Customer is responsible for insuring that the database is regularly backed up; and for controlling access to the server.
All records are saved with a checksum (hash sum) to ensure integrity of records and to protect records against tampering. Every time a record is opened or shown, the checksum is recalculated and compared to the original checksum. If the checksums don’t mach, a message is displayed.
11.10 (d) Limiting system access to authorized individuals.
Access to the IMSXpress system is controlled by log in user name and password. Following password security policies can be set:
  • Password length and complexity requirements
  • Password expiration period (password aging)
  • Preventing reuse of passwords
  • Require changing password on first log-in
  • Inactivity logout period
11.10 (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
In IMSXpress records are never overwritten or deleted. A modified record is saved as a new version of the record without overwriting the original record. Deleted records are flagged ‘Deleted’ but are not actually deleted from the database. All versions of a record and ‘Deleted’ records are identified with a time stamp and an identification of the logged in user who created, modified or deleted the record. The time stamp is the server time in a universal time format.
All record versions and ‘Deleted’ records can be viewed and printed out in the Audit Trail module. Audit trail records are protected by checksums and cannot be altered or deleted.
11.10 (f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
IMSXpress has built in operational system checks to enforce workflow steps that preserve the integrity of electronically signed records. For example, all electronically signed documents and records are sealed and cannot be modified after the signature is executed. Another example is automatic, sequential numbering of records.
11.10 (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
IMSXpress has the following security levels:
  • System Administrator
  • Module Administrator
  • Authorization (use of electronic signature)
  • Delete Record/Document
  • Alter Record/Document
  • Read Only
11.10 (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
IMSXpress can only receive input from the keyboard and mouse device. The use of keyboard and mouse is implicitly tested throughout the validation of the software.
IMSXpress has built in check routines and validation rules to ensure that data entered into data fields is of correct type, length and/or range.
11.10 (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
The use of electronic signatures is explained in the IMSXpress Tutorial. The tutorial is integrated into the software and is immediately available to all users.
11.10 (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
Customer is responsible for establishing and enforcing pertinent procedures.
11.10 (k)(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
Documentation for operation and maintenance IMSXpress software is integrated into the software itself, and is thus immediately available to all users.
11.10 (k)(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
System documentation is integrated into the software itself and is developed, validated and released as integral part of each software version.
11.30 Controls for open systems
Not applicable
11.50 Signature manifestations
11.50 (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
11.50 (a)(1) The printed name of the signer;
11.50 (a)(2) The date and time when the signature was executed; and
11.50 (a)(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Signed electronic records identify the signer name and position, the (server) date and time when the signature was executed, and the meaning associated with the signature.
11.50 (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
The information required in 11.50(a) is controlled and protected in the same way as the record itself (protected with a checksum, never overwritten and never deleted).
All this information is clearly displayed (printed) on the record itself.
11.70 Signature/record linking
11.70 Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
The electronic signature information is embedded into the signed record itself (as additional columns) and is protected by a common checksum. Any attempt to excise, copy, or otherwise transfer the signature will invalidate the record checksum (hash sum).
11.100 General requirements
11.100 (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
Electronic signature consists of a signer code and password that the signer sets up personally. The signer code and password are only known to the signer, and cannot be reassigned or reused.
11.100 (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
Customer is responsible for compliance with this requirement.
11.100 (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures
Customer is responsible for compliance with this requirement.
11.200 Electronic signature components and controls
11.200 (a)(1) Employ at least two distinct identification components such as an identification code and password.
(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
IMSXpress employs two distinct identification components in the electronic signature: signer code and password.
Every individual signing requires the use of both components.
11.200 (a)(2) Be used only by their genuine owners.
Signing code and password are personally set by the signature owner and are known only to that individual.
11.200 (a)(3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
Signer code and password cannot be set by the System Administrator. To set a signer code and password the user must be logged in to his or her IMSXpress account and must know his or her log in name and password.
11.200 (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
Not applicable
11.300 Controls for identification codes/passwords
11.300 (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.
Before accepting a new combination of signer code and password the system checks whether the combination is unique.
11.300 (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).
Following signer password security policies can be set:
  • Password length and complexity requirements
  • Password expiration period (password aging)
  • Preventing reuse of passwords
11.300 (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.
System Administrators can disable electronic signing privilege for any user and can reset the signer code and password. After the code and password are reset, the user must set up new signing credentials. Users can also change their signing credentials at any time.
11.300 (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.
To use her electronic signature the user must be also logged in to her account. Every electronic signing is traceable to:
  • Windows/server user account
  • IMSXpress user account
  • Computer on which the signature was executed
  • Server time stamp
11.300 (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.
All software elements related to set up, changes, reset, etc. of electronic signature signer code and password are formally validated for each software version release.